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K Number
K051782
Device Name
BLUEPHASE 16I
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2005-09-20

(81 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental light-curing device called "Bluephase 16i." It certifies that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed presentation of performance studies against acceptance criteria.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.